MAUDE Adverse Event Report: Hamilton Medical AG HAMILTON-C6

Model Number	160021
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer states: on (b)(6).2026, during ventilation, the device displayed the error message ¿o¿ sensor failed¿ and stopped displaying the o¿ value.The fio¿ was set to 30% when the message appeared.The patient¿s oxygen saturation subsequently decreased and stabilized at 91%.The fio¿ was then increased to 100%, and the typical sound of oxygen flowing into the device during flushing was immediately heard.The device was replaced.No permanent patient harm was reported.
Additional Manufacturer Narrative
Hamilton medical ag reference number:(b)(4) investigation ongoing.

• Brand Name: HAMILTON-C6
• Common Device Name: HAMILTON-C6
• Manufacturer (Section D): Hamilton Medical AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: via crusch 8; bonaduz 7402
• MDR Report Key: 50942632
• Report Number: 3001421318-2026-00604
• Device Sequence Number: 21206975
• Product Code: CBK
• UDI-Device Identifier: 07630002808590
• UDI-Public: (01)07630002808590(11)260320(240)160021
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K201658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 160021
• Device Catalogue Number: 160021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 03/20/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown